A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated … (NCT02000375) | Clinical Trial Compass
TerminatedPhase 2
A Phase II Study Evaluating the Role of Androgen Receptors as Targets for Therapy of Pre-treated Post-menopausal Patients With ER/PgR-negative/AR-positive or ER and/or PgRpositive/ AR-positive Metastatic Breast Cancer (ARTT)
Stopped: Due to slow recruitment and recent new published data
Italy20 participantsStarted 2013-03
Plain-language summary
A phase II non randomized study evaluating the role of Androgen Receptors as Targets for therapy of pre-treated postmenopausal patients with ER/PgR-negative/AR-positive or ER and/or PgR-positive/AR-positive metastatic breast cancer.
Study Design: Multicentric, Open-label not randomized trial.
Description of Study Treatment:
Daily oral administration of DHEA (Dehydroepiandrosterone) at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption until discontinuation for progression of disease, unacceptable toxicity or discontinuation/withdrawal of participants from study treatment.
Number of Subjects:
12 patients per group in the first step; if the number of responders is greater or equal to 2, recruitment will continue up to a total of 35 patients (per group).
For the biological part, we will evaluate:
1. Correlation between AR expression and clinical and biological features (tumor size, nodal status, histotype, grading, proliferative index, ER, PgR, HER2)
2. Evaluation of AR expression on primitive and/or metastatic site in the two distinct populations of patients: ER/PgR- negative/ARpositive and ER-positive and/or PgR-positive/AR-positive
3. Evaluation of ER, PgR, HER2 expression on tumor cells of metastatic site (when it is possible) and comparison with the same features of primitive tumor.
4. CTCs analysis in term of molecular characteristics (gene expression and mutations) and functionality (vitality and tumorigenicity).
5. Prognostic and predictive role of Circulating Tumor Cells (CTC) evaluated at baseline before study treatment and at the moment of discontinuation of treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histological-documented diagnosis of invasive breast cancer.
. Clinical diagnosis of metastatic breast cancer.
. AR receptor positivity of primary tumor cells or tumor cells of a metastatic site is required. It is strongly recommended that 4 unstained and freshly cut 3-4 μ slides from the primary tumor (or metastatic if the primary is not available) be submitted for IRCCS IRST Laboratorio di Bioscienze for confirmation of AR eligibility; however, if that is not possible, a formalin-fixed paraffin-embedded (FFPE) tissue block will be submitted .
. Primary tumor cells or tumor cells of a metastatic site can be ER-positive and/or PgRpositive or ER-negative/PgR-negative . Hormone receptor positivity is defined as ER and/or PgR greater than 10 fmol/mg by biochemical assay or greater or equal than 10 percent positive cells by immunohistochemistry.
. Primary tumor cells or tumor cells of a metastatic site must be HER2 negative.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical benefit rate (CB)
Timeframe: 36 months
Trial details
NCT IDNCT02000375
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
. Measurable disease, defined in accord to RECIST criteria (version 1.1) as
. at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with CT scan or MRI (if slice thickness no grater than 5 mm. If slice thicknesses grater than 5 mm the minimum size miserable lesions at baseline should be twice the slice thickness of baseline scans)
. to be considered pathologically enlarged and measurable, a lymph node must be ≥ 15 mm in short axis when assessed by CT scan or MRI (if slice thickness no grater than 5 mm. If slice thicknesses grater than 5 mm the minimum size miserable nodes at baseline).
Exclusion criteria
. AR-receptor negativity of primary tumor cells or tumor cells of a metastatic site. AR is reported as negative if less than 10% of cells immunostained in a tumor.
. HER2 positivity of primary tumor cells or tumor cells of a metastatic site
. Physician opinion of a too rapid disease progression (like disease widespread in visceral organs like liver or lung in few months) that could suggest the physician a more benefit from chemotherapy treatment even if eligibility criteria for enrollment are satisfied
. Chemotherapy administration within 3 weeks prior to start of protocol therapy or not recovered from adverse events due to agents administered more than 3 weeks earlier
. Brain metastasis not treated or in progression requiring treatment (radiotherapy, surgery or high dose steroidal and antiedemigen treatment) in the 2 weeks prior to start of protocol therapy. Patients with brain metastasis as unique site of metastasis are excluded
. Have received supplement of estrogen or progesterone within 4 weeks prior to study enter
. Major surgery during the 21 days before before starting of protocol therapy or planned during the study treatment
. Other detectable malignant neoplastic diseases (even a second primitive breast cancer) in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix)